Compare Subperiosteal and Loco-Regional Anesthesia in Posterior Mandible Dental Implant Installation

Implantology Institute

Status and phase: Active, not recruiting; Phase 4

Conditions: Anesthesia Complications; Surgical Complications From Local Anesthesia; Anesthesia Morbidity; Dental Implant Failed

Treatments: Device: Dental Implants in Posterior Mandible; Drug: Loco-regional 1:100.000 Articaine 4% epinephrine; Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01963754

II-03

Details and patient eligibility

About

In patients that are going to receive a dental implant in the posterior mandible (distal from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ?

Full description

Inter/Intra observer agreement will be made for administration of local subperiosteal, loco-regional anesthesia, operatory evaluation of pain and radiologic examination.

One group will receive articaine 1:100.000, 4% epinephrine subperiosteal and the other 1:100.000 4% epinephrine loco-regional for dental implant installation in posterior mandible.

The evaluation parameters will focus on intraoperatory pain, Intraoperatory anesthetic complications, anesthetic efficiency, correlation between distance from implant to inferior alveolar nerve, intraoperatory pain, post-operatory at 3 and 10 days and correlate changes, and survival rate of dental implants during and post osseointegration period.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Single unit implant rehabilitation
• Maxilla and mandible
• Must accept treatment plan
• Must sign informed consent
• dental extraction performed at least 3 month prior
• Must have at least 6 mm of residual bone
• Absence of oral lesions
• keratinized tissue must be present

Exclusion criteria

• If smoking and/or other drug addiction is present
• If local anesthetic allergy is present
• Patient subjected to chemical or radiotherapy
• if Hepatic disease is present
• If immunodepression is present
• If Pregnancy is present
• If Diabetes is present
• If Heart disease is present

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

88 participants in 2 patient groups

Subepriosteal Articaine

Experimental group

Description:

Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible

Treatment:

Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine

Device: Dental Implants in Posterior Mandible

Loco-regional Articaine

Active Comparator group

Description:

Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible

Treatment:

Drug: Loco-regional 1:100.000 Articaine 4% epinephrine

Device: Dental Implants in Posterior Mandible